Methods and systems for facilitating stimulation of one or more stimulation sites

ABSTRACT

Methods of facilitating stimulation of a stimulation site within a patient include implanting a distal portion of a first stimulating member such that the distal portion of the first stimulating member is in communication with a first stimulation site located within a patient, securing the distal portion of the first stimulating member at a first securing site with a first securing device positioned proximal to the first stimulation site, forming a first loop of at least 360 degrees with a portion of the first stimulating member proximal to the first securing device, securing the first loop with a second securing device at a second securing site having a position that is greater than or equal to substantially 180 degrees but less than or equal to substantially 315 degrees along the first loop from the first securing site, and positioning the second securing device and a stimulator to be coupled to a proximal end of the first stimulating member to maintain a curve in the first stimulating member of at least 45 degrees between the second securing device and the stimulator.

RELATED APPLICATIONS

The present application is a continuation-in-part application of U.S.application Ser. No. 11/259,176, filed Oct. 25, 2005, which applicationclaims the benefit of U.S. Provisional Application Ser. No. 60/661,700filed Mar. 14, 2005. Both applications are incorporated herein byreference in their respective entireties.

BACKGROUND

The public health significance of many medical, psychiatric, andneurological conditions and/or disorders is often overlooked, probablybecause of their episodic nature and the lack of mortality attributed tothem. However, some medical conditions, such as headaches and facialpain, are often incapacitating, with considerable impact on socialactivities and work, and may lead to the significant consumption ofdrugs.

Migraine headaches are a particular form of headache, usually veryintense and disabling. Migraines are a neurological disease thought tobe of vascular origin. They are characterized by attacks of sharp painusually involving one half of the skull and may be accompanied bynausea, vomiting, phonophobia, photophobia and occasionally visual,olfactory or balance disturbances known as aura. The symptoms and theirtiming vary considerably among migraine sufferers and, to a lesserextent, from one migraine attack to the next. Migraine is oftenconnected with the expansion of the blood vessels of the head and neck.

Conventional treatments for migraines focus on three areas: triggeravoidance, symptomatic control, and preventive drugs. Each of these willbe discussed below.

In a minority of patients, the incidence of migraines can be reducedthrough diet changes to avoid certain chemicals that serve as triggersfor migraines. These chemical triggers may be present in such foods ascheddar cheese and chocolate, and in most alcoholic beverages. Othertriggers may be situational and some can be avoided through lifestylechanges. Such triggers may include particular points in the menstrualcycle, certain weather patterns, or hunger. Bright flashing lights mayalso be a trigger. Most migraine sufferers are sensitive to and avoidbright or flickering lights.

If a migraine occurs despite trigger avoidance, the next step intreatment is symptomatic control. Caffeine and simple pain killers,analgesics, such as paracetamol, aspirin or low doses of codeine aresometimes, but not often, effective. Narcotic pain medications, such asheroin, morphine, and other opiates, provide variable relief. However,many of these drugs are addictive and can cause undesirable sideeffects.

Various drugs may also be administered on a regular basis to prevent theonset of migraines. Exemplary preventive drugs include beta blockers(e.g., propranolol or atenolol), antidepressants, and antispasmodicdrugs. However, many of these drugs are ineffective in preventingmigraines.

SUMMARY

Methods of facilitating stimulation of a stimulation site within apatient include implanting a distal portion of a first stimulatingmember such that the distal portion of the first stimulating member isin communication with a first stimulation site located within a patient,securing the distal portion of the first stimulating member at a firstsecuring site with a first securing device positioned proximal to thefirst stimulation site, forming a first loop of at least 360 degreeswith a portion of the first stimulating member proximal to the firstsecuring device, securing the first loop with a second securing deviceat a second securing site having a position that is greater than orequal to substantially 180 degrees but less than or equal tosubstantially 315 degrees along the first loop from the first securingsite, coupling a proximal end of the first stimulating member to astimulator, and positioning the stimulator and the second securingdevice to maintain a curve in the first stimulating member of at least45 degrees between the second securing device and the stimulator.

Systems for facilitating stimulation of a stimulation site within apatient include a first stimulating member having a distal portionconfigured to be in communication with a first stimulation site within apatient and a proximal portion configured to be formed into a first loopof at least 360 degrees, a stimulator coupled to a proximal end of thefirst stimulating member, and first and second securing devicesconfigured to secure the first stimulating member to at least onesecuring site. The first securing device is configured to secure thedistal portion of the first stimulating member at a first securing siteand the second securing device is configured to secure the first loop ata second securing site having a position that is greater than or equalto substantially 180 degrees but less than or equal to substantially 315degrees along the first loop from the first securing site. The secondsecuring device is further configured to maintain a curve in the firststimulating member of at least 45 degrees between the second securingdevice and the stimulator.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of theprinciples described herein and are a part of the specification. Theillustrated embodiments are merely examples and do not limit the scopeof the disclosure.

FIG. 1A depicts the upper cervical spine area of a patient and shows anumber of nerves originating in the upper cervical spine area.

FIG. 1B depicts the occipital nerves in the back of the head and upperneck area of a patient.

FIG. 1C illustrates a view of the major nerves and arteries in the humanhead as viewed from above looking down on the top or superior part ofthe head.

FIG. 2 illustrates an exemplary implantable stimulator according toprinciples described herein.

FIG. 3 illustrates an exemplary microstimulator according to principlesdescribed herein.

FIG. 4 shows an example of a microstimulator with one or more leadscoupled thereto according to principles described herein.

FIG. 5 depicts a number of stimulators configured to communicate witheach other and/or with one or more external devices according toprinciples described herein.

FIG. 6 illustrates an exemplary lead configuration according toprinciples described herein.

FIG. 7A is a perspective view of an exemplary suture sleeve according toprinciples described herein.

FIG. 7B is a top view of the suture sleeve illustrated in FIG. 7Aaccording to principles described herein.

FIGS. 7C-7D show perspective views of additional exemplary suturesleeves according to principles described herein.

FIG. 8 illustrates another exemplary lead configuration according toprinciples described herein.

FIG. 9 is a cross-sectional view of an implanted suture sleeve accordingto principles described herein.

FIG. 10 is a flow chart illustrating an exemplary method of facilitatingstimulation of one or more stimulation sites within a patient accordingto principles described herein.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

Methods and systems for facilitating stimulation of at least onestimulation site within a patient are described herein. The methods andsystems may be used to treat a variety of medical conditions such as,but not limited to, headaches, occipital neuralgia, facial pain, and/orconditions treated with spinal cord stimulation.

In some examples, a distal portion of a stimulating member (e.g., a leadand/or a catheter) is implanted such that it is in communication with astimulation site located within a patient. A first securing device maythen be used to secure the distal portion of the stimulating member at afirst securing site positioned proximal to the stimulation site. A loopof at least 360 degrees may then be formed with a portion of thestimulating member that is proximal to the first securing device. Theloop may be secured with a second securing device at a second securingsite having a position that is greater than or equal to substantially180 degrees along the loop from the first securing site but less than orequal to substantially 315 degrees along the loop from the firstsecuring site. The stimulator (which will be coupled to the proximal endof the stimulating member) and the stimulating member may be positionedto maintain the loop and to maintain a curve in the stimulating memberof at least 45 degrees between the second securing device and thestimulator.

In the following description, for purposes of explanation, numerousspecific details are set forth in order to provide a thoroughunderstanding of the present systems and methods. It will be apparent,however, to one skilled in the art that the present systems and methodsmay be practiced without these specific details. Reference in thespecification to “one embodiment” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one embodiment. Theappearance of the phrase “in one embodiment” in various places in thespecification are not necessarily all referring to the same embodiment.

FIG. 1A depicts the upper cervical spine (C1-C4) area of a patient. Asshown in FIG. 1A, a number of nerves arise from the upper cervical spine(C1-C4). Examples of such nerves include, but are not limited to, thegreater occipital nerve(s) 101, lesser occipital nerve(s) 102, greaterauricular nerve(s) 103, transverse cervical nerve(s) 104,supraclavicular nerve(s) 105, and/or branches of any of these nerves.

FIG. 1B depicts the occipital nerves 100 in the back of the head andupper neck area of a patient. As shown in FIG. 1B, the occipital nerves100 are divided into greater 101 and lesser 102 occipital nerves. Theoccipital nerves 100 lie subcutaneously in the back of the head andupper neck and are therefore are relatively easily accessed.

FIG. 1C illustrates a view of the major nerves and arteries in the humanhead as viewed from above looking down on the top or superior part ofthe head. As shown in FIG. 1C, the greater occipital nerves 101 extendto and across some of the top or superior portion of the head. Thelesser occipital nerves 102 may also extend to or near the top orsuperior portion of the head.

It is believed that applying a stimulus to one or more of the nerveswithin in the head and/or neck may be effective in treating one or moremedical conditions. For example, the stimulus may be configured toalleviate or eliminate headache. However, it will be recognized that anyother medical condition (e.g.; occipital neuralgia, facial pain,conditions treated with spinal cord stimulation, etc.) may be treated inaccordance with the systems and methods described herein.

Consequently, a stimulator may be implanted within a patient to delivera stimulus to one or more stimulation sites within the head and/or neckin order to treat one or more medical conditions. The presentspecification describes methods and systems for implanting such astimulator within the patient.

The stimulation sites referred to herein may include any nerve, tissue,blood vessel, or other area within a patient. It will be recognized thatalthough the exemplary stimulation sites described in connection withthe examples given herein are located within the head and/or neck, oneor more of the stimulation sites may additionally or alternatively belocated anywhere within a patient. For example, the methods and systemsdescribed herein may be used in connection with spinal cord stimulation,wherein the stimulation site is located along the spinal cord andwherein the stimulator is implanted at a surgically convenient location(e.g., within the buttocks).

As used herein, and in the appended claims, the term “stimulator” isused broadly to refer to any device that delivers a stimulus, such as anelectrical stimulation current, one or more drugs, chemical stimulation,thermal stimulation, electromagnetic stimulation, mechanicalstimulation, and/or any other suitable stimulation to a stimulationsite. Thus, the term “stimulator” includes, but is not limited to, amicrostimulator, an implantable pulse generator (IPG), a system controlunit (stimulator), an external trial stimulator, or similar device.

To facilitate an understanding of the methods and systems describedherein, a more detailed description of a stimulator and its operationwill now be given with reference to the figures. FIG. 2 illustrates anexemplary stimulator 120 that may be used to apply a stimulus to astimulation site within a patient, e.g., an electrical stimulation ofthe stimulation site, an infusion of one or more drugs at thestimulation site, or both. The electrical stimulation function of thestimulator 120 will be described first, followed by an explanation ofthe possible drug delivery function of the stimulator 120. It will beunderstood, however, that the stimulator 120 may be configured toprovide only electrical stimulation, only drug stimulation, both typesof stimulation, or any other type of stimulation as best suits aparticular patient.

The exemplary stimulator 120 shown in FIG. 2 is configured to provideelectrical stimulation to one or more stimulation sites within a patientand may include at least one lead 121 coupled thereto. In some examples,the at least one lead 121 includes a number of electrodes 122 throughwhich electrical stimulation current may be applied to a stimulationsite. It will be recognized that the at least one lead 121 may includeany number of electrodes 122 arranged in any configuration as bestserves a particular application.

As illustrated in FIG. 2, the stimulator 120 includes a number ofcomponents. It will be recognized that the stimulator 120 may includeadditional and/or alternative components as best serves a particularapplication. A power source 125 is configured to output voltage used tosupply the various components within the stimulator 120 with powerand/or to generate the power used for electrical stimulation. The powersource 125 may include a primary battery, a rechargeable battery (e.g.,a lithium-ion battery), a super capacitor, a nuclear battery, amechanical resonator, an infrared collector (receiving, e.g., inffaredenergy through the skin), a thermally-powered energy source (where,e.g., memory-shaped alloys exposed to a minimal temperature differencegenerate power), a flexural powered energy source (where a flexiblesection subject to flexural forces is part of the stimulator), abioenergy power source (where a chemical reaction provides an energysource), a fuel cell, a bioelectrical cell (where two or more electrodesuse tissue-generated potentials and currents to capture energy andconvert it to useable power), an osmotic pressure pump (where mechanicalenergy is generated due to fluid ingress), or the like.

In some examples, the power source 125 may be recharged using anexternal charging system. One type of rechargeable power supply that maybe used is described in U.S. Pat. No. 6,596,439, which is incorporatedherein by reference in its entirety. Other battery constructiontechniques that may be used to make the power source 125 include thoseshown, e.g., in U.S. Pat. Nos. 6,280,873; 6,458,171; 6,605,383; and6,607,843, all of which are incorporated herein by reference in theirrespective entireties.

The stimulator 120 may also include a coil 128 configured to receiveand/or emit a magnetic field (also referred to as a radio frequency (RF)field) that is used to communicate with, or receive power from, one ormore external devices. Such communication and/or power transfer mayinclude, but is not limited to, transcutaneously receiving data from theexternal device, transmitting data to the external device, and/orreceiving power used to recharge the power source 125.

For example, an external battery charging system (EBCS) 111 may beprovided to generate power that is used to recharge the power source 125via any suitable communication link. Additional external devicesincluding, but not limited to, a hand held programmer (HHP) 115, aclinician programming system (CPS) 117, and/or a manufacturing anddiagnostic system (MDS) 113 may also be provided and configured toactivate, deactivate, program, and/or test the stimulator 120 via one ormore communication links. It will be recognized that the communicationlinks shown in FIG. 2 may each include any type of link used to transmitdata or energy, such as, but not limited to, an RF link, an infrared(IR) link, an optical link, a thermal link, or any other energy-couplinglink.

Additionally, if multiple external devices are used in the treatment ofa patient, there may be communication among those external devices, aswell as with the implanted stimulator 120. It will be recognized thatany suitable communication link may be used among the various devicesillustrated.

The external devices shown in FIG. 2 are merely illustrative of the manydifferent external devices that may be used in connection with thestimulator 120. Furthermore, it will be recognized that the functionsperformed by any two or more of the external devices shown in FIG. 2 maybe performed by a single external device.

The stimulator 120 may also include electrical circuitry 124 configuredto generate the electrical stimulation current that is delivered to astimulation site via one or more of the electrodes 122. For example, theelectrical circuitry 124 may include one or more processors, capacitors,integrated circuits, resistors, coils, and/or any other componentconfigured to generate electrical stimulation current.

Additionally, the exemplary stimulator 120 shown in FIG. 2 may beconfigured to provide drug stimulation to a patient by applying one ormore drugs at a stimulation site within the patient. To this end, a pump127 may also be included within the stimulator 120. The pump 127 isconfigured to store and dispense one or more drugs, for example, througha catheter 123. The catheter 123 is coupled at a proximal end to thestimulator 120 and may have an infusion outlet 129 for infusing dosagesof the one or more drugs at the stimulation site. In some embodiments,the stimulator 120 may include multiple catheters 123 and/or pumps 127for storing and infusing dosages of the one or more drugs at thestimulation site.

The pump 127 described herein may include any of a variety of differentdrug delivery systems. For example, exemplary pumps 127 suitable for useas described herein include, but are not limited to, those disclosed inU.S. Pat. Nos. 3,760,984; 3,845,770; 3,916,899; 3,923,426; 3,987,790;3,995,631; 3,916,899; 4,016,880; 4,036,228; 4,111,202; 4,111,203;4,203,440; 4,203,442; 4,210,139; 4,327,725; 4,360,019; 4,487,603;4,627,850; 4,692,147; 4,725,852; 4,865,845; 5,057,318; 5,059,423;5,112,614; 5,137,727; 5,234,692; 5,234,693; 5,728,396; and 6,368,315.All of these listed patents are incorporated herein by reference intheir respective entireties.

The stimulator 120 may also include a programmable memory unit 126configured to store one or more stimulation parameters. The stimulationparameters may include, but are not limited to, electrical stimulationparameters, drug stimulation parameters, and other types of stimulationparameters. The programmable memory unit 126 allows a patient,clinician, or other user of the stimulator 120 to adjust the stimulationparameters such that the stimulation applied by the stimulator 120 issafe and efficacious for treatment of a particular patient. Theprogrammable memory unit 126 may include any type of memory unit suchas, but not limited to, random access memory (RAM), static RAM (SRAM), ahard drive, or the like.

The electrical stimulation parameters may control various parameters ofthe stimulation current applied to a stimulation site including, but notlimited to, the frequency, pulse width, amplitude, waveform (e.g.,square or sinusoidal), electrode configuration (i.e., anode-cathodeassignment), burst pattern (e.g., burst on time and burst off time),duty cycle or burst repeat interval, ramp on time, and ramp off time ofthe stimulation current that is applied to the stimulation site. Forexample, at least one of the pulse width, frequency, amplitude, andinter-pulse interval (i.e., the delay between adjacent stimulationpulses) may be continuously adjusted to minimize patient accommodationto the stimulation.

The drug stimulation parameters may control various parametersincluding, but not limited to, the amount of drugs infused at thestimulation site, the rate of drug infusion, and the frequency of druginfusion. For example, the drug stimulation parameters may cause thedrug infusion rate to be intermittent, constant, or bolus. Otherstimulation parameters that characterize other classes of stimuli arepossible. For example, when tissue is stimulated using electromagneticradiation, the stimulation parameters may characterize the intensity,wavelength, and timing of the electromagnetic radiation stimuli. Whentissue is stimulated using mechanical stimuli, the stimulationparameters may characterize the pressure, displacement, frequency, andtiming of the mechanical stimuli.

The stimulator 120 of FIG. 2 is illustrative of many types ofstimulators that may be used in accordance with the systems and methodsdescribed herein. For example, the stimulator 120 may include animplantable pulse generator (IPG), a spinal cord stimulator (SCS), adeep brain stimulator, a drug pump, an external trial stimulator, or anyother type of stimulation device configured to deliver a stimulus to astimulation site within a patient. Exemplary IPGs suitable for use asdescribed herein include, but are not limited to, those disclosed inU.S. Pat. Nos. 6,381,496, 6,553,263; and 6,760,626. Exemplary spinalcord stimulators suitable for use as described herein include, but arenot limited to, those disclosed in U.S. Pat. Nos. 5,501,703; 6,487,446;and 6,516,227. Exemplary deep brain stimulators suitable for use asdescribed herein include, but are not limited to, those disclosed inU.S. Pat. Nos. 5,938,688; 6,016,449; and 6,539,263.

All of these listed patents are incorporated herein by reference intheir respective entireties.

The stimulator 120 of FIG. 2 may alternatively include amicrostimulator, such as a BION® microstimulator (Advanced Bionics®Corporation, Valencia, Calif.). Various details associated with themanufacture, operation, and use of implantable microstimulators aredisclosed in U.S. Pat. Nos. 5,193,539; 5,193,540; 5,312,439; 6,185,452;6,164,284; 6,208,894; and 6,051,017. All of these listed patents areincorporated herein by reference in their respective entireties.

FIG. 3 illustrates an exemplary microstimulator 130 that may be used asthe stimulator 120 described herein. Other configurations of themicrostimulator 130 are possible, as shown in the above-referencedpatents and as described further below.

As shown in FIG. 3, the microstimulator 130 may include the power source125, the programmable memory 126, the electrical circuitry 124, and thepump 127 described in connection with FIG. 2. These components arehoused within a capsule 132. The capsule 132 may be a thin, elongatedcylinder or any other shape as best serves a particular application. Theshape of the capsule 132 may be determined by the structure of thedesired stimulation site and the method of implantation. In someexamples, the microstimulator 130 may include two or more leadlesselectrodes 133 disposed on the outer surface of the microstimulator 130.

The external surfaces of the microstimulator 130 may advantageously becomposed of biocompatible materials. For example, the capsule 132 may bemade of glass, ceramic, metal, or any other material that provides ahermetic package that will exclude water vapor but permit passage ofelectromagnetic fields used to transmit data and/or power. Theelectrodes 133 may be made of a noble or refractory metal or compound,such as platinum, iridium, tantalum, titanium, titanium nitride, niobiumor alloys of any of these, in order to avoid corrosion or electrolysiswhich could damage the surrounding tissues and the device.

The microstimulator 130 may also include one or more infusion outlets131 configured to dispense one or more drugs directly at a stimulationsite. Alternatively, one or more catheters may be coupled to theinfusion outlets 131 to deliver the drug therapy to a treatment sitesome distance from the body of the microstimulator 130.

FIG. 4 shows an example of a microstimulator 130 with one or more leads140 coupled thereto. As shown in FIG. 4, each of the leads 140 mayinclude one or more electrodes 141 disposed thereon. As shown in FIG. 4,the microstimulator 130 may additionally or alternatively include one ormore leadless electrodes 133 disposed on the outer surface thereof.

In some examples, the stimulator 120 of FIG. 2 may be configured tooperate independently. Alternatively, as shown in FIG. 5, the stimulator120 may be configured to operate in a coordinated manner with one ormore additional stimulators, other implanted devices, or other devicesexternal to the patient's body. FIG. 5 illustrates an exemplaryconfiguration wherein a first stimulator 120-1 implanted within thepatient 151 provides a stimulus to a first location, a second stimulator120-2 provides a stimulus to a second location, and a third stimulator120-3 provides a stimulus to a third location. In some examples, one ormore external devices 150 may be configured to control the operation ofeach of the implanted devices 120. In some embodiments, an implanteddevice, e.g., stimulator 120-1, may control, or operate under thecontrol of, another implanted device(s), e.g., stimulator 120-2 and/orstimulator 120-3. Control lines 152 have been drawn in FIG. 5 toillustrate that the external device 150 may communicate or provide powerto any of the implanted devices 120 and that each of the variousimplanted devices 120 may communicate with and, in some instances,control any of the other implanted devices.

As a further example of multiple stimulators 120 operating in acoordinated manner, the first and second stimulators 120-1 and 120-2 ofFIG. 5 may be configured to sense various indicators of the symptoms orcauses of a particular medical condition and transmit the measuredinformation to the third stimulator 120-3. The third stimulator 120-3may then use the measured information to adjust its stimulationparameters and apply stimulation to a stimulation site accordingly. Thevarious implanted stimulators may, in any combination, sense indicatorsof a particular medical condition, communicate or receive data regardingsuch indicators, and adjust stimulation parameters accordingly.

In order to determine the strength and/or duration of electricalstimulation and/or amount and/or type(s) of stimulating drug(s) requiredto most effectively treat a particular medical condition, variousindicators of the medical condition and/or a patient's response totreatment may be sensed or measured. The stimulator 120 may then adjustthe stimulation parameters (e.g., in a closed loop manner) in responseto one or more of the sensed indicators. Exemplary indicators include,but are not limited to, electrical activity of the brain (e.g., viaelectroencephalography (EEG)), neurotransmitter levels, hormone levels,metabolic activity in the brain, blood flow rate, medication levelswithin the patient, patient input, temperature of the stimulation site,physical activity level, brain hyperexcitability, indicators ofcollateral tissue stimulation, and/or muscle tone in neck (e.g.,mechanical strain, pressure sensor, electromyography (EMG)). In someexamples, the stimulator 120 may be configured to perform themeasurements. Alternatively, other sensing devices may be configured toperform the measurements and transmit the measured values to thestimulator 120. Exemplary sensing devices include, but are not limitedto, chemical sensors, electrodes, optical sensors, mechanical (e.g.,motion, pressure) sensors, and temperature sensors.

Thus, one or more external devices may be provided to interact with thestimulator 120, and may be used to accomplish at least one or more ofthe following functions:

Function 1: If necessary, transmit electrical power to the stimulator120 in order to power the stimulator 120 and/or recharge the powersource 125.

Function 2: Transmit data to the stimulator 120 in order to change thestimulation parameters used by the stimulator 120.

Function 3: Receive data indicating the state of the stimulator 120(e.g., battery level, drug level, stimulation parameters, etc.).

Additional functions may include adjusting the stimulation parametersbased on information sensed by the stimulator 120 or by other sensingdevices.

As mentioned, one or more stimulation sites within a patient may bestimulated by a stimulator 120 to treat a variety of different medicalconditions. For example, it is believed that stimulation of one or moreof the occipital nerves may be effective in treating headache.Additional or alternative stimulation sites within the head and/or neckthat may be stimulated in order to treat headache include, but are notlimited to, one or more of the cranial nerves, the trigeminal nerve, theinfraorbital nerve, the facial nerve, the maxillary nerve, themandibular nerve, and branches thereof.

Hence, as will be described in more detail below, one or more leads 121with one or more electrodes 122 disposed thereon may be implanted withina patient such that the electrodes 122 are in communication with one ormore stimulation sites within the patient. As used herein, the term “incommunication with” refers to the electrodes 122 being adjacent to, inthe general vicinity of, in close proximity to, directly next to, ordirectly on the stimulation site. For example, with reference to FIGS.1B and 1C, the one or more leads 121 may be implanted in the patient'sneck at or near the base of the skull, at the back of the head, on thetop or superior portion of the skull, or at any other suitable location.

However, one of the issues with using a stimulator 120 with one or moreleads 121 coupled thereto to stimulate a stimulation site within apatient is lead migration. For example, an implantable stimulator 120and its associated lead(s) 121 are generally implanted on a long-term orpermanent basis: However, with time and with the natural movement of thepatient, a lead 121 coupled to an implanted stimulator 120 may move awayfrom the location where it was first implanted. For example, a simplenod of the head may cause a lead 121 that is not securely implantedwithin the neck to shift positions. Likewise, twisting of the torso maycause a lead 121 that is not securely implanted within the back to shiftpositions. This tendency to move is known as lead migration, or simply,migration.

Hence, the systems and methods described herein may be used to minimizeand/or eliminate lead migration. FIG. 6 illustrates an exemplary leadconfiguration wherein multiple leads 121 with a number of electrodes 122disposed on a distal portion 163 thereof are implanted such that one ormore of the electrodes 122 are in communication with one or more of theoccipital nerves 100. The number of electrodes 122 disposed on each lead121 may vary as may serve a particular application and lead size.

In some examples, as will be described in more detail below, eachelectrode 122 may be selectively programmed to have a positive (anode),negative (cathode), or OFF polarity to create a particular stimulationfield when current is applied. Thus, different combinations ofprogrammed anode and cathode electrodes 122 may be used to deliver avariety of current waveforms at one or more stimulation sites. Moreover,any of the other stimulation parameters (e.g., frequency, pulse width,amplitude, burst pattern, duty cycle, ramp on time, and ramp off time)of the stimulation current delivered by each of the electrodes 122 maybe individually programmed. In this manner, as will be described in moredetail below, current steering (also referred to as neuronavigation ore-trolling) may be used after the leads 121 are implanted to tailor thestimulation to the needs of a particular patient.

As shown in FIG. 6, the lead configuration may include two leads (e.g.',121-1 and 121-2, collectively referred to herein as 121). In thisexample, a distal portion 163-1 of the first lead 121-1 is positionedover the greater occipital nerve 101-1 on the right side of the patientand a distal portion 163-2 of the second lead 121-2 is placed over thegreater occipital nerve 101-2 on the left side of the patient. Thedistal portions 163 of the leads 121 shown in FIG. 6 and in the otherexamples described herein are straight for illustrative purposes only.It will be recognized that the distal portions 163 may alternatively becurved, helical, paddle-shaped, or of any other shape as may serve aparticular application.

The distal portions 163 of each of the leads 121 shown in FIG. 6 coverthe greater occipital nerves 101 for illustrative purposes only. It willbe recognized that the leads 121 may be located at any other stimulationsite (e.g., the lesser occipital nerve 102) as may serve a particularapplication. In some examples, the distal tip of each of the leads 121is placed four to five centimeters from the midline (i.e., the medialline or plane of the body) to minimize the need to advance the leads 121following insertion. However, it will be recognized that the leads 121may be placed any distance from the midline.

Configurations having two leads 121, such as that shown in FIG. 6, areadvantageous in applications wherein it is desirable to applystimulation to multiple stimulation sites. For example, the leadconfiguration of FIG. 6 may be used to simultaneously apply stimulationto locations on both the right and left sides of the patient. However,it will be recognized that a single lead 121 or more than two leads 121may be used in accordance with the systems and methods described herein.

The leads 121 are shown in FIG. 6 to be implanted over the patient'sneck at or near the base of the skull in the C1 region. The leads 121may additionally or alternatively be implanted over the scalp of thepatient or at any other suitable location.

A number of suture sleeves 160 may be used to help minimize or eliminatemigration of the leads 121 within the patient. FIG. 7A is a perspectiveview of an exemplary suture sleeve 160 that may be used in accordancewith the systems and methods described herein. FIG. 7B is a top view ofthe suture sleeve 160 illustrated in FIG. 7A. As shown in FIG. 7A, thesuture sleeve 160 includes a main body 170 with a lumen 171 extendingtherethrough. The lumen 171 is dimensioned so as to allow passagetherethrough of one of the leads 121.

As shown in FIGS. 7A-7B, one or more slits 172 may be included along themain body 170 of the suture sleeve 160 through which an adhesive may beinserted into the lumen 171 to secure the lead 121 to the suture sleeve160. In some examples, the adhesive may initially be in a liquid stateand solidify upon being inserted into the lumen 171. In this manner, theadhesive may be configured to minimize the risk of lead slippage ormigration. Any suitable surgical adhesive may be used including, but notlimited to, cyanoacrylate, Duraseal™, TRUFILL® n-BCA, BioGlue™ SurgicalAdhesive, Tisseal, Fibrin, and Med A.

The slit 172 also serves to prevent bunching as a suture is tied aroundthe main body 170 of the suture sleeve 160. The suture that is tiedaround the main body 170 of the suture sleeve 160 will be described inmore detail below.

FIGS. 7A-7B show that the suture sleeve 160 may also include a number ofwing members 173 extending away from the main body 170. Each of the wingmembers 173 includes a hole 174 through which a suture can be sewn tosecure the suture sleeve 160 in place, for example, to fascia. Thesuture sleeve 160 shown in FIGS. 7A-7B includes two wing members 173 forillustrative purposes only. It will be recognized that any number ofwing members 173 may be included through which sutures may be sewn toanchor the suture sleeve 160 in place. Additionally or alternatively,the suture sleeve 160 may include one or more anchors, hooks, adhesives,or other securing devices that are configured to secure the suturesleeve 160 in place.

FIGS. 7C-7D show variations of the suture sleeves 160 that may be usedin connection with the systems and methods described herein. Forexample, as shown in FIG. 7C, the suture sleeve 160 may be generallycylindrically shaped and include multiple slits 172 extendingtherethrough. Additionally or alternatively, as shown in FIG. 7D, thesuture sleeve 160 may include a number of grooves 175 disposed on itsmain body 170. These grooves 175 may be configured to guide and retainplacement of one or more sutures that are used to secure the lead 121 inplace. It will be recognized the suture sleeves 160 may includeadditional or alternative features as may serve a particularapplication.

Returning to FIG. 6, each lead 121 is secured by one or more suturesleeves 160—e.g., a distal suture sleeve 160-1 and a proximal suturesleeve 160-2. The proximal suture sleeve 160-2 is closer to thestimulator (not shown) than is the distal suture sleeves 160-1. It willbe recognized that any number of suture sleeves 160 may be used tosecure the leads 121 in place. Moreover, it will be recognized that anyother securing device may additionally or alternatively be used tosecure the leads 121 in place. Such securing devices may include, butare not limited to, one or more sutures, hooks, adhesives, or anchors.

Each suture sleeve 160 may be sutured into place using one or moresutures 161. In some examples, the sutures are non-absorbable. Exemplarynon-absorbable sutures that may be used to suture the suture sleeves 160into place include, but are not limited to, a braided nylon (e.g.,Nurolon), a braided polyester (e.g., Ethibond or Mersiline), Prolene,Surgilene, Tevdek, a polypropylene material, a braided polyestermaterial, and a Teflon coated polyester material.

In some examples, at least two sutures 161 are used to affix aparticular suture sleeve 160 to fascia. These sutures 161 may bethreaded through the holes 174 that are a part of the wing members 173.At least one additional suture 161 may be cinched around the main body170 of the suture sleeve 160 to prevent slippage of the lead 121 withinthe suture sleeve 160. Although three sutures 161 are illustrated asaffixing each suture sleeve 160 in FIG. 6, it will be recognized thatany number of sutures 161 may be used to affix each suture sleeve 160 asmay serve a particular application.

In some examples, each distal suture sleeve 160-1 may be sutured orotherwise fixed to fascia or any other securing site that is located inthe same rostro-caudal motion segment as the most proximal electrode 122on the lead 121 to minimize relative movement between the targetstimulation site (e.g., the greater occipital nerve 101) and the distalsuture sleeve 160-1. For example, if the most proximate electrode 122 tothe distal suture sleeve 160-1 is located in the C2 region, the distalsuture sleeve 160-1 is sutured to fascia in the same C2 region.Likewise, if the most proximate electrode 122 to the distal suturesleeve 160-1 is located in the scalp region, the distal suture sleeve160-1 is sutured to fascia overlying the scalp.

As shown in FIG. 6, the long axis of each distal suture sleeve 160-1 issubstantially collinear with the long axis of the electrode region ofits corresponding lead 121. Each lead 121 passes through the lumen 171of its corresponding distal suture sleeve 160-1 and then forms a loop(e.g., 162-1 and 162-2, collectively referred to herein as 162) of atleast 360 degrees. To this end, the leads 121 are configured to passthrough corresponding proximal sleeves 160-2, which are positioned so asto maintain the shape of the loops 162. The leads 121 may then be routedto the stimulator (not shown). The portion of the leads 121 that makesup each loop 162 may be made out of any flexible material.

The loops 162 are configured to minimize the forces that are exerted onthe distal and proximal sutures sleeves 160-1 and 160-2 when the patientmoves his or her head. Hence, the loops 162 are also referred to as“force redirection loops” herein. The force redirection loops 162 arealso configured to minimize lead migration. Hence, the force redirectionloops 162 may be dimensioned and aligned such that there are minimalforces on either the distal or proximal suture sleeve 160-1 or 160-2.

In some examples, each lead 121 crosses the midline prior to forming itscorresponding force redirection loop 162. For example, as shown in FIG.6, the electrode portion of lead 121-1 is located on the right side ofthe midline. The lead 121-1 crosses the midline prior to forming forceredirection loop 162-1. Lead 121-2 also crosses the midline prior toforming force redirection loop 162-2. Hence, the leads 121 cross eachother prior to forming force redirection loops 162. Alternatively, aswill be described in more detail below, the leads 121 may be positionedsuch that they form force redirection loops 162 without crossing eachother.

As mentioned, each lead 121 passes through a corresponding proximalsuture sleeve 160-2 in forming a force redirection loop 162. As shown inFIG. 6, the long axis of each proximal suture sleeve 160-2 may besubstantially perpendicular to the midline or spine. This placementminimizes lead migration that may be caused by the flexion or extensionof the neck. Such flexion or extension of the neck may cause theproximal suture sleeve 160-2 to bend, however, the risk of the lead 121slipping within the suture sleeve 160-2 is minimized when the proximalsuture sleeve 160-2 is perpendicular to the midline or spine.Alternatively, as will be described in more detail below, the long axisof the proximal suture sleeve 160-2 may be oriented in any non-paralleldirection with respect to the midline.

After the leads 121 pass through corresponding proximal suture sleeves160-2, the leads 121 are routed to a stimulator 120. In some examples,as will be described in more detail below, the leads 121 may form one ormore additional loops prior to being coupled to the stimulator 120. Itwill be recognized that one or more devices, such as the stimulator 120,may be implanted in any suitable location within the body. For example,the stimulator 120 may be implanted above the iliac crest or over theribcage to minimize the path of the leads 121 and to minimize the needfor multiple lead extensions. Other exemplary implant locations mayinclude, but are not limited to, the buttocks, neck, brain, andsubcutaneous area on top of the skull, or any other suitable locationwithin the patient.

FIG. 8 illustrates an alternative lead configuration that may be used inconnection with the systems and methods described herein. The leadconfiguration of FIG. 8 is similar to that described in connection withFIG. 6 in that the configuration includes multiple leads 121 and suturesleeves 160 configured to secure the leads 121 in place. The leads 121may each include one or more electrodes 122 disposed thereon and areimplanted such that one or more of the electrodes 122 are incommunication with one or more stimulation sites (e.g., the greateroccipital nerves 101).

As shown in FIG. 8, each distal suture sleeve 160-1 may be substantiallycollinear with the long axis of the distal portion 163 of itscorresponding lead 121. Each distal suture sleeve 160-1 is sutured orotherwise fixed to fascia or any other securing site that is located,for example, in the same vertebral level as the most proximal electrode122 on the lead 121 to minimize relative movement between the targetstimulation site (e.g., the greater occipital nerve 101) and the distalsuture sleeve 160-1. For example, if the most proximate electrode 122 tothe distal suture sleeve 160-1 is located in the C2 region, the distalsuture sleeve 160-1 is sutured to fascia in the same C2 region.Likewise, if the most proximate electrode 122 to the distal suturesleeve 160-1 is located in the scalp region, the distal suture sleeve160-1 is sutured to fascia overlying the scalp.

As described previously in connection with the example of FIG. 6, eachlead 121 passes through the lumen 171 of its corresponding distal suturesleeve 160-1 and then forms a force redirection loop (e.g., 162-1 and162-2) of at least 360 degrees before passing through the proximalsleeves 160-2. However, as shown in the example of FIG. 8, each lead 121forms the force redirection loop 162 without crossing the other lead121. For example, lead 121-1 forms force redirection loop 162-1 withoutcrossing lead 121-2. In some examples, each lead 121 forms a forceredirection loop 162 without crossing the midline.

As shown in FIG. 8, proximal suture sleeves 160-2 may be providedthrough which the leads 121 pass. In some examples, each proximal suturesleeve 160-2 may be located at a securing site having a position that isgreater than or equal to substantially 180 degrees but less than orequal to substantially 315 degrees along its corresponding forceredirection loop 162 as measured from the securing site of its distalsuture sleeve 160-1.

To illustrate, a point along the force redirection loop 162-2corresponding to approximately 180 degrees from the loop's correspondingdistal suture sleeve 160-1 is labeled “A”. Likewise, a point along theforce redirection loop 162-2 corresponding to approximately 315 degreesfrom the loop's corresponding distal suture sleeve 160-1 is labeled “B”.Hence, the proximal suture sleeve 160-2 corresponding to the forceredirection loop 162-2 shown in FIG. 8 is located in between points Aand B.

In some examples, the long axis of each proximal suture sleeve 160-2 isaligned so as to maintain a curve in its corresponding lead 121 of atleast 45 degrees between the proximal suture sleeve 160-2 and thestimulator 120. As used herein, the term “maintain a curve” andvariations thereof mean ensuring that a curve of at least 45 degreespersists even if the lead 121 is pulled taut between the proximal suturesleeve 160-2 and the stimulator 120. In this manner, the risk of thelead 121 slipping within the suture sleeves 160 is minimized. In someparticular examples, the long axis of each proximal suture sleeve 160-2is aligned so as to maintain a curve in its corresponding lead 121 of atleast 90 degrees between the proximal suture sleeve 160-2 and thestimulator 120.

To illustrate an example of this, FIG. 8 shows a configuration whereineach proximal suture sleeve 160-2 is located at a point along itscorresponding force redirection loop 162 such that the lumen of eachproximal suture sleeve 160-2 is substantially perpendicular to thedistal portion 163 of its corresponding lead 121, and thus is alsosubstantially perpendicular to the lumen of its corresponding distalsuture sleeve 160-1. Such a configuration may be used to maintain acurve in the leads 121 of at least 45 degrees between the proximalsuture sleeves 160-2 and the stimulator 120.

In some examples, the proximal suture sleeves 160-2 are placed caudal toC1 to avoid undesirable suturing over the stimulation site (e.g., thegreater occipital nerve 101).

After passing through the proximal suture sleeves 160-2, the leads 121may each be formed into one or more additional loops (e.g., 180-1 and180-2, collectively referred to herein as 180) prior to being routed tothe stimulator 120. These additional loops 180 may relieve strain thatmay be placed on the leads 121 by changing size as the patient moves.Hence, these additional loops 180 are referred to herein as “strainrelief loops” for illustrative purposes.

FIG. 8 shows that the strain relief loops 180 may be formed at the baseof the neck. Additionally or alternatively, the strain relief loops 180may be formed at any other suitable location as may serve a particularapplication.

In some examples, the strain relief loops 180 are located within apocket made by a surgeon in the subcutaneous fat and are not sutured orotherwise affixed to tissue. In this manner, the fat retains the generalshape of the strain relief loops 180 while allowing the loops 180 tovary in size as the patient moves.

Additionally or alternatively, the leads 121 may each form a strainrelief loop at or near the location of the stimulator 120. For example,if the stimulator 120 is implanted over the ribcage, lead(s) 121 mayform one or more strain relief loops at or near the rib cage just priorto being coupled to the stimulator 120.

As mentioned, each suture sleeve 160 described herein may be affixed tofascia. FIG. 9 is a cross-sectional view of an exemplary implantedsuture sleeve 160. As shown in FIG. 9, the suture sleeve 160 with a lead121 disposed therethrough may be located within subcutaneous fat 190located directly beneath the skin 191. The bottom surface of the suturesleeve 160 is coupled to the fascia 192, which is a thin layer offibrous tissue that separates the subcutaneous fat 190 from muscle 193.

A number of methods may be used to locate the optimal implantation sitefor the leads 121. For example, an insulated regional nerve block needleor other probe may be used to identify the location of a desired nerve(e.g., the greater occipital nerve 101) prior to or during the implantprocedure. The leads 121 may then be implanted such that the electrodes122 disposed thereon are in communication with the desired nerve.

Additionally, the patient is often awake and under a local anesthesiafor the implantation procedure. Consequently, obtaining verbal feedbackfrom the patient as to the effect of a trial stimulation or variousstimulation parameters may be useful in obtaining the most beneficiallead placement and stimulation current parameters. However, it is oftendifficult to hear the patient due to the orientation of the patient andthe dressings used around the implantation procedure. Consequently, amicrophone may be placed at or near the patient's mouth. The soundtransduced by the microphone may be amplified and/or output through aspeaker where it is clearly audible to the personnel performing thetesting or implantation of the leads 121. Other patient feedback systemsand methods may be used including, but not limited to, keypads, remotecontrols and other communication devices.

Once the leads 121 are implanted, current steering (also referred to asneuronavigation or e-trolling) may be used to tailor the stimulation tothe needs of a particular patient. U.S. Pat. No. 6,393,325, which isincorporated herein by reference in its entirety, discloses an exemplarymethod of current steering that may be used in connection with thepresent methods and systems.

By way of example, another exemplary method of using current steering tooptimize the stimulation parameters for a particular patient may becarried out according to the following sequence of procedures. Forillustrative purposes only, it will be assumed in the example givenbelow that it is desired to apply stimulation to one or more of theoccipital nerves 130. The steps listed below may be modified, reordered,and/or added to as best serves a particular application.

1. Beginning with the most distal electrode 122 disposed on the leftlead 121-2, steer down until the patient begins reporting paresthesias.Continue steering down one electrode at a time and identify where alongthe lead 121-2 the paresthesia is the highest and the most intense.Patient feedback and/or some other monitoring device may be used tosignal where the paresthesia is the highest and most intense. Mark thislocation as the optimal stimulation location along this lead 121-2.

2. Repeat step 1 above for the right lead 121-1.

3. For each lead 121, evaluate the distance of the optimal electrodefrom the midline. If the distance is greater than 30 mm in the neckregion, the optimal stimulation site is most likely the lesser occipitalnerve 102.

4. If the optimal stimulation site found in step 3 is the lesseroccipital nerve 102, repeat steps 1-3 to add a second stimulation sitefor both leads 121 which is less than 30 mm from the midline. Thisstimulation site covers the greater occipital nerve 101.

In some instances, it may be desirable to measure the amount of leadmigration that occurs over a specific amount of time. For this purpose,a radioopaque bead may be implanted within the patient over the centerof the occipital protuberance to provide a landmark in the radiographicplane of the leads. After the lead implant procedure is complete, a trueAP fluoroscopic image of the leads 121 and the bead may be printed.Should lead migration be suspected in the future, a second x-ray may betaken with a bead over the occipital protuberance to allow quantitativeassessment of lead migration.

An exemplary method of facilitating stimulation of one or morestimulation sites within a patient will now be given in connection withthe flow chart of FIG. 10. The steps illustrated in FIG. 10 may bemodified, reordered, and/or added to as may serve a particularapplication. For instance, steps 204 and 205 shown in FIG. 10 may bereversed.

In step 200, a distal portion 163 of a lead 121 is implanted such thatthe distal portion 163 is in communication with a stimulation sitelocated within a patient. The stimulation site may be located within thehead, neck, spinal cord, or at any other location within the patient asmay serve a particular application.

The distal portion 163 of the lead 121 is secured at a first securingsite with a first securing device (e.g., a suture sleeve or simply asuture) positioned proximal to the stimulation site, as shown in step201.

A force redirection loop of at least 360 degrees is formed with aportion of the lead 121 that is proximal to the first securing device,as shown in step 202. In step 203, the force redirection loop is securedwith a second securing device (e.g., a suture sleeve or simply a suture)at a second securing site. The second securing site may be located at aposition that is greater than or equal to substantially 180 degrees butless than or equal to substantially 315 degrees along the forceredirection loop 162 as measured from the first securing site.

In step 204, a proximal end of the lead 121 is secured to a stimulator120. In some examples, the stimulator may be at least partiallyimplanted within the patient.

In step 205, the stimulator and second securing device are positioned tomaintain a curve in the lead 121 ofat least 45 degrees between thesecond securing device and the stimulator 120. In this manner, slippageof the lead 121 within the securing devices may be minimized.

The examples given herein describe various systems and methods forimplanting stimulating leads 121. However, it will be recognized thatthe systems and methods described herein may additionally oralternatively be used in connection with the implantation of catheters.

The preceding description has been presented only to illustrate anddescribe embodiments of the invention. It is not intended to beexhaustive or to limit the invention to any precise form disclosed. Manymodifications and variations are possible in light of the aboveteaching.

1. A method comprising: implanting a distal portion of a firststimulating member at a site located to the right of a midline of apatient such that said distal portion of said first stimulating memberis in communication with a first stimulation site located within thehead or neck of said patient; implanting a distal portion of a secondstimulating member at a site located to the left of said midline suchthat said distal portion of said second stimulating member is incommunication with a second stimulation site located within the head orneck of said patient; forming a first loop of at least 360 degrees witha proximal portion of said first stimulating member at a site located tothe right of said midline; forming a second loop of at least 360 degreeswith a proximal portion of said second stimulating member at a sitelocated to the left of said midline; securing each of said loops totissue with at least one securing device; and coupling proximal ends ofsaid first and second stimulating members to at least one stimulator. 2.The method of claim 1, wherein said sites of said first and second loopsare located within an upper portion of said neck, and wherein saidmethod further comprises: forming a third loop of at least 360 degreeswith said proximal portion of said first stimulating member at a sitelocated within a lower portion of said neck and to the right of saidmidline; and forming a fourth loop of at least 360 degrees with saidproximal portion of said second stimulating member at a site locatedwithin a lower portion of said neck and to the left of said midline. 3.The method of claim 1, wherein said first and second stimulating memberseach comprise a lead with one or more electrodes disposed thereon, andwherein said method further comprises applying a stimulus generated bysaid at least one stimulator to at least one of said stimulation sitesvia at least one of said electrodes.
 4. The method of claim 1, whereinsecuring each of said loops to tissue with said at least one securingdevice comprises: securing said first loop with a first securing deviceto maintain a curve in said first stimulating member of at least 45degrees between said first securing device and said at least onestimulator; and securing said second loop with a second securing deviceto maintain a curve in said second stimulating member of at least 45degrees between said second securing device and said at least onestimulator.
 5. A system comprising: a first stimulating member having adistal portion configured to be in communication with a firststimulation site within a patient and a proximal portion configured tobe formed into at least a first loop of at least 360 degrees; astimulator coupled to a proximal end of said first stimulating member;and first and second securing devices configured to secure said firststimulating member to first and second securing sites; wherein saidfirst securing device is configured to secure said distal portion ofsaid first stimulating member at said first securing site; wherein saidsecond securing device is configured to secure said first loop at saidsecond securing site having a position that is greater than or equal tosubstantially 180 degrees but less than or equal to substantially 315degrees along said first loop from said first securing site; and whereinsaid second securing device is further configured to maintain a curve insaid first stimulating member of at least 45 degrees between said secondsecuring device and said stimulator.
 6. The system of claim 5, furthercomprising: a second stimulating member having a distal portionconfigured to be in communication with a second stimulation site withinsaid patient, a proximal portion configured to be formed into a secondloop of at least 360 degrees, and a distal end configured to be coupledto said stimulator; third and fourth securing devices configured tosecure said second stimulating member to third and fourth securingsites; wherein said third securing device is configured to secure saiddistal portion of said second stimulating member at said third securingsite; wherein said fourth securing device is configured to secure saidsecond loop at said fourth securing site having a position that isgreater than or equal to substantially 180 degrees but less than orequal to substantially 315 degrees along said second loop from saidthird securing site; and wherein said fourth securing device is furtherconfigured to maintain a curve in said second stimulating member of atleast 45 degrees between said fourth securing device and saidstimulator.
 7. The system of claim 5, wherein said first and secondsecuring devices each comprise a suture sleeve having a lumen configuredto facilitate passage therethrough of said first stimulating member. 8.The system of claim 7, wherein: said lumen of said first securing deviceis configured to be substantially collinear with said distal portion ofsaid first stimulating member; and said lumen of said second securingdevice is configured to be substantially perpendicular to said distalportion of said first stimulating member.
 9. The system of claim 5,wherein said first stimulating member comprises at least one of a leadhaving at least one electrode disposed thereon and a catheter.
 10. Thesystem of claim 5, wherein said fourth securing device is furtherconfigured to maintain a curve in said second stimulating member of atleast 90 degrees between said fourth securing device and saidstimulator.